Kornimate/medical-research-clean huggingface dataset:
stem cell educator therapy in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the translational potential to the clinical applications of cord blood stem cells has increased enormously in recent years, mainly because of its unique advantages including no risk to the donor, no ethical issues, low risk of graft-versus-host disease (gvhd), rapid availability, and large resource worldwide. human cord blood contains several types of stem cells such as the umbilical cord blood-derived multipotent stem cells (cb-sc). cb-sc possess multiple biological properties including the expression of embryonic stem (es) cell characteristics, giving rise to different types of cells and immune modulation. specifically, cb-sc can function as an immune modulator that can lead to control of the immune responses, which could in turn be used as a new approach to overcome the autoimmunity of type 1 diabetes (t1d) in patients1 and nonobese diabetic (nod) mice. here, the investigators develop a novel stem cell educator therapy by using cb-sc and explore the therapeutic effectiveness of educator therapy in t1d patients.


Eligibility criteria:
inclusion criteria: * patients were screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards of american diabetes association 2010. other key inclusion criteria were presence of at least one autoantibody to the pancreatic islet β cells. exclusion criteria: * exclusion criteria were any clinically significant diseases in liver, kidney, and heart. additional exclusion criteria were no pregnancy, no immunosuppressive medication, no viral diseases or diseases associated with immunodeficiency.

Keywords: cord blood stem cells immune modulation stem cell educator autoimmunity islet beta cell regeneration type 1 diabetes
virtual parental presence on induction

Conditions: Anxiety; Surgery

Summary: our goal in this study is to investigate the feasibility and acceptability of virtual parental presence of parents on anxiety in children at induction of anesthesia at cincinnati children's hospital, an institution whose use of parental presence on induction is deeply ingrained in our culture, and to determine the impact of coaching of parents either prior to arrival at the hospital vs. on the day of surgery on efficacy of virtual parental presence on induction. our primary hypothesis is that virtual ppia is both feasibile for the smooth induction of general anesthesia and is acceptable to parents, patients, and anesthesia providers at our isntutition. our secondary hypothesis is that the coaching of parents prior to virtual ppia enhances the effect of video parental presence at induction of anesthesia on children's anxiety and that coaching prior to arrival at the hospital will allow for increased ease and use of this technique.


Eligibility criteria:
inclusion criteria: * children from ages 4 years to 12 years old * asa physical status i, ii or iii * planned inhalational induction * children presenting from home prior to surgery (not an inpatient) * english speaking parents and child exclusion criteria: * children with developmental delay * children with psychological / emotional disorders * children with altered mental status * children with language barrier * children who are not accompanied by someone able to consent (ie legal guardian) * children who are inpatient prior to surgery * children with expected difficult intubation/airway * children presenting for emergency surgery * family history or personal history of malignant hyperthermia / risk of mh * consent not obtained or withdrawl of consent * children with past history of violent behaviors during induction of anesthesia * cancellation of surgery * patients with a diagnosis of covid-19 or a patient under investigation for covid-19, including patients being treated with airborne precuations in the operating room * receipt of any type of medical sedative prior to induction of anesthesia, including (but not limited to) midazolam, ketamine, and/or dexmedetomidine.
pathogenesis of pediatric obsessive-compulsive disorder: based on the microbiota-gut-brain axis

Conditions: Obsessive-Compulsive Disorder; Tic Disorder

Summary: this study aims to investigate the characteristics of the microbiota-gut-brain axis in pediatric patients with obsessive-compulsive disorder (ocd) through performing an integrated analysis of gut microbiota, serum metabolomics, neuroimaging and electroencephalography (eeg), conducted before and after treatment with selective serotonin reuptake inhibitors (ssris). the results will be compared with those of pediatric ocd paitents comorbid with tic disorder (td) and healthy controls. the findings are expected to further elucidate the potential pathogenesis of ocd, providing a theoretical basis for identifying novel clinical intervention targets and optimizing treatment strategies.


Eligibility criteria:
we recruited outpatient children and adolescents with ocd confirmed by the kiddie schedule for affective disorders and schizophrenia for school-age children-present and lifetime version (4th edition). the following inclusion and exclusion criteria were also applied: inclusion criteria: (1) 7-17 years old, (2) y-bocs score ≥16, (3) with or without a history of td, (4) drug-naïve or drug-free for 8 weeks, (5) wechsler iq score ≥ 80. exclusion criteria: * history of serious medical, neurological illness or other psychotic disorders other than ocd (tic disorder excepted). * previous exposure to cognitive behavioral therapy (cbt) for ocd or td. * serious suicide risk. * has taken antibiotics, probiotics, prebiotics, corticosteroids, nonsteroidal anti-inflammatory drugs (nsaids), or immunosuppressants within the past 8 weeks. * has a history of gastrointestinal diseases such as inflammatory bowel disease, irritable bowel syndrome, constipation, hemorrhoids, or a history of gastrointestinal surgery, or has a history of autoimmune diseases such as rheumatoid arthritis or systemic lupus erythematosus. * participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.

Keywords: microbiota-gut-brain axis pediatric ocd microbiome
prevalence and prediction of attr in ambulatory patients with hfpef

Conditions: Transthyretin Amyloidosis; Heart Failure; Heart Failure, Diastolic; Amyloidosis

Summary: recent studies have shown that transthyretin amyloidosis (attr) can sometimes cause a type of heart failure where the pumping function of the heart is normal, also known as heart failure with preserved ejection fraction (hfpef) or diastolic heart failure. in this single center diagnostic study, we will evaluate for attr in patients with hfpef in order to to determine how frequently this occurs and how we can predict which heart failure patients may have ttr amyloidosis. our goal is to identify amyloidosis in heart failure patients earlier so that they can start treatment.

patients 65-years and older with hfpef will be enrolled to participate in this single center, event driven (positive nuclear amyloid scan also known as 99mtc-pyrophosphate spect scan) study. during the single study visit the following will be obtained: * 99mtc-pyrophosphate spect scan * blood and dna (optional) sample collection * questionnaires in regards to neuropathy, carpal tunnel, frailty, and heart failure symptoms and how they may affect ones quality of life * 6-minute walk test * ecg (electrocardiogram) * echocardiogram electronic health records will be reviewed for up to 5 years in order to determine hospitalization and survival of the study participants. clinical outcomes of interest include a combined endpoint of days alive outside of the hospital from heart failure hospitalizations at one and five years, presence of autonomic neuropathy, presence of carpal tunnel syndrome, presence of polyneuropathy. additionally, individual clinical endpoints are also endpoints of interest. the results from this study will be used to determine how frequently heart failure patients have transthyretin amyloidosis in their heart and better understand their symptoms. we hope that better understanding transthyretin amyloidosis in heart failure patients will help us identify affected patients so that they can receive treatment.

Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of hfpef. * age ≥65 years old exclusion criteria: * end stage chronic kidney disease on dialysis (ckd stage 5 as defined as egfr \<15ml/min) * no history of hfref (lvef\<40%) with the exception of low lvef in the setting of acute decompensation, af rvr, acs/mi, etc * negative 99mtc-pyrophosphate scan within a year * unable to lie down for 15 minutes for the 99mtc-pyrophosphate scan * known diagnosis of amyloidosis * severe valvular heart disease that is uncorrected (moderate to severe is considered exclusionary)

Keywords: transthyretin amyloidosis heart failure heart failure, diastolic amyloidosis
milk-induced gastrointestinal symptoms in infants

Conditions: Gastrointestinal Symptoms in Young Infants

Summary: various digestive manifestations are common in infants less than 6 months and have a significant impact on morbidity and quality of life of the family. in a prospective study on more than 2800 italian infants followed by 0-6 months of life, it was determined that 55% of these children had gastrointestinal symptoms such as regurgitation (23%), colics (20%), constipation (17%) or poor weight gain (15%). however, these symptoms are not very accurate, and their cause is often difficult to determine. frequently, the pediatrician will exclude cow's milk protein in infant feeding, but without a clear etiological diagnosis was asked. this measure causes significant additional costs through the use of extensively hydrolyzed milk specifically for children and involves an elimination diet of all foods containing cow's milk sometimes for several years. this can negatively influence the growth of the child. if the involvement of milk in these pathologies is suggested by some early studies (35% for colics, 68% in constipation, 42% in gastroesophageal reflux), it is unclear in the current state of knowledge if these gastrointestinal symptoms are actually due to an "allergy" to milk. moreover, there is no validated diagnostic test for non-ige-mediated gut allergy. however, various tests have proven their effectiveness in the investigation of non ige-mediated allergy (eg. lat, patch tests) and will be used in this study.


Eligibility criteria:
inclusion criteria: * infants 0-6 month old with at least one of the following symptoms : constipation, gastroesophageal reflux, colics exclusion criteria: * prematurity * exclusive breastfeeding * other cause for symptoms

Keywords: constipation gastroeosphageal reflux colics
hpv vaccination among daughters of latina immigrants

Conditions: Cervical Cancer; Healthy Diet

Summary: the overall goal of this study to promote hpv vaccine uptake among daughters of latina immigrants between the ages of 9 and 12.

objective: implementation and examination of the efficacy of a culturally relevant, community-based hpv vaccination intervention among daughters of latina immigrants 9-12 years of age in alabama. methods: group-randomized controlled trial evaluating two interventions: 1) promotion of hpv vaccination and 2) promotion of healthy eating using "place of residence" as the unit of randomization. between may 2013 and october 2017, forty locations with 317 mother-daughter dyads were enrolled.

Eligibility criteria:
inclusion criteria: * latina immigrant * resident of selected randomization unit (place of residence) * 18 years of age and older * at least one hpv unvaccinated daughter between the ages of 9 and 12 exclusion criteria: -

Keywords: hpv vaccination healthy eating latina immigrants
a study of brigatinib to treat adults with anaplastic lymphoma kinase (alk) positive metastatic non small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell Lung; Anaplastic Lymphoma Kinase

Summary: the aims of the study are to assess the safety profile of brigatinib and the clinical response rates in adults with anaplastic lymphoma kinase (alk)-positive metastatic non small cell lung cancer (nsclc). treatment with brigatinib and follow-up will be according to routine clinical practice. study doctors will review the participants' medical records at the start of the study, then at 12 and 24 weeks after treatment starts.

this is a prospective, observational post-marketing surveillance study of brigatinib in participants with advanced or metastatic nsclc. this study will assess the safety, efficacy and effectiveness of brigatinib for its approved indications in a routine clinical practice setting under real world use. the study will enroll approximately 37 participants. the data will be collected both prospectively and/or retrospectively at the specialized centers and outpatient oncology clinics and will be recorded by the investigator in the electronic case report form (ecrf) based on the routine medical care data that is collected in the medical records. all the participants will be assigned to a single observational cohort: • all participants this multi-center study will be conducted in argentina. the overall duration of the study will be approximately 52 weeks. data collection will be based on routine visit after every 12 weeks from the start of treatment up to 24 weeks of follow up or death or cancer progression or treatment discontinuation, whichever occurs first.

Eligibility criteria:
inclusion criteria: 1. with either a diagnosis of alk positive metastatic nsclc previously treated with crizotinib or a diagnosis of alk positive metastatic nsclc previously not treated with an alk inhibitor. have received at least one dose of brigatinib according to approved indications. exclusion criteria: note: there are no specific exclusion criteria.

Keywords: drug therapy
edoxaban treatment in routine clinical practice for patients with non valvular atrial fibrillation

Conditions: Atrial Fibrillation

Summary: in order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the non-valvular atrial fibrillation (nvaf) indication, daiichi-sankyo proposed this post-authorization safety study (pass) to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other drug related adverse events) of edoxaban use in patients with nvaf who were not preselected.

patients will be from 10 different european countries and care settings (primary and secondary care and different specialties). a one-year patient recruitment period per country is planned, but it could be longer if patient recruitment numbers are not reached. patient data will be documented at baseline (bl), one annual data documentation point during the four-year follow up (fu), and at final assessment. patients who permanently discontinue edoxaban during the observation period will continue to be followed annually for a further two years, or until the end of the observational period (whichever comes first).

Eligibility criteria:
inclusion criteria: * nvaf-patients treated with edoxaban according to summary of product characteristics (smpc). * written informed consent for participation in the study (icf). * not simultaneously participating in any interventional study. exclusion criteria: * none

Keywords: nonvalvular atrial fibrillation post authorisation safety study safety real world evidence
integrated treatment for posttraumatic stress disorder and substance abuse in young adults

Conditions: Substance Use Disorder; Posttraumatic Stress Disorder

Summary: the purpose of the study is to determine the safety and efficacy of an integrated treatment for substance abuse and posttraumatic stress disorder for young adults. the integrated treatment includes two established psychosocial treatments for substance abuse (contingency management) and posttraumatic stress disorder (prolonged exposure therapy).


Eligibility criteria:
inclusion criteria: * 18-25 years old * meets diagnostic criteria for substance use disorder * meets diagnostic criteria for full or subthreshold posttraumatic stress disorder * currently able to provide a urine drug screen that is negative for cocaine, prescription opiates, and non-prescribed methadone or provided this type of screen in the past 60 days * speaks english exclusion criteria: * significant cognitive impairment or serious uncontrolled psychiatric problem (other than posttraumatic stress disorder) * in recovery from pathological gambling or current pathological gambling diagnosis * in a current domestic violence relationship
silicone gel versus onion extract gel as prevention for postsurgical scars

Conditions: Hypertrophic or Keloid Scars

Summary: hypertrophic or keloid scars develop for about 39% to 68% of patients after surgery. the subjective opinion of the patient regarding the scar will often constitute the standard for judging the success or failure of the procedure. surgical scars are not only a cosmetic concern but they can also cause pain, itching, discomfort, contracture, and other functional impairment. various treatment options exists for treating hypertrophic scars and keloids, including intralesional steroid injection, dermabrasion, pressure therapy, surgical excision, radiotherapy, cryotherapy, pulse dye, and carbon dioxide laser ablation. however, these treatments often require multiple visits and have limited success. therefore, prevention and early recognition of hypertrophic scars and keloids are very important in their management. among preventive treatments available, silicone gel and onion extract gel have been marketed as products to improve the appearance and texture of surgical scars. despite its popularity, data demonstrating the efficacy of these gels are lacking. furthermore, there is no comparative study of silicone gel and onion extract gel for preventing postsurgical hypertrophic or keloid scars. the investigators therefore conducted this randomized controlled trial to compare the efficacy of silicone gel and onion extract gel for the prevention of postsurgical hypertrophic scars. the investigators also compared patient compliance and side effect between two topical gels.


Eligibility criteria:
inclusion criteria: 1. over 18 years of age, 2. asian, 3. at least 3 cm sized surgical wound in total length, 4. nonpregnant at the time of presentation (i.e., negative for urine pregnancy test or last menstrual period within the last 4 weeks), 5. able to read and write informed consent and questionnaire. exclusion criteria: 1. women who received nearly scar-free surgery such as laparoendoscopic single-site (less) surgery or natural orifice transluminal surgery (notes); 2. women who developed surgical complications such as wound infection 3. women who had a history of hypertrophic or keloid scarring in abdomen 4. women who were taking chemotherapeutic agents or other medications that would affect wound healing, such as steroids 5. women who had comorbidities such as diabetes, contractive skin disorders (e.g., scleroderma), or active dermatologic conditions 6. women who had allergy to silicone or onion.
salivary flow rate response to electrostimulation in hd patients

Conditions: Hemodialysis Complication

Summary: xerostomia is a subjective complaint of dry mouth, whereas hyposalivation is an objective decreased of salivary flow. hyposalivation was reported in 28.8 % of haemodialysis (hd) patients (bruzda-zwiech, 2014).

stimulation of the salivary glands can be induced mechanically (for example, by chewing gum or acupressure) or through medications (such as pilocarpine, cevimeline, angiotensin-converting-enzyme inhibitors and angiotensin-receptor blockers) or by electrostimulation as transcutnaeous electrical nerve stimulation (tens) (bossola and tazza, 2012). eighty hd patients (40 diabetics and 40 nondiabetics) will receive 20 minutes of tens on skin over bilateral parotid gland, 3 times weekly for 3 weeks to investigate the hyposalivation response of diabetic and non diabetic hd patients to tens.

Eligibility criteria:
inclusion criteria: * eighty hd patients (40 diabetics and 40 non diabetics) * hd at least from three month * saliva flow less than or equal 0.15 millilitre per minute exclusion criteria: * pulmonary or cardiac disorders * drugs to treat hyposalivation * salivary glands inflammation, tumor, and autoimmune diseases. * smokers and alcholics
development of vitamin d as a therapy for breast cancer - phase 2

Conditions: Breast Cancer

Summary: this study will assess whether levels of vitamin d impact the characteristics of a woman's breast cancer at diagnosis, and whether a short course of vitamin d in women with low levels of vitamin d changes the gene expression of their breast cancers.

patients undergoing core needle biopsy of breast abnormalities suspicious for breast cancer will be identified and enrolled in study. as well as those who have had a core needle biopsy demonstrating breast cancer, but who have not yet undergone local surgical treatment, chemotherapy, or hormonal therapy are also eligible. patients with breast cancer on core biopsy will be eligible. participants will be assigned to treatment (0, 2000, 4000, 6000 iu/day vitamin d by mouth) based solely on their serum vitamin d levels (normal: \>40 ng/ml; low-normal: 31-40 ng/ml; low: 20-30 ng/ml; very-low: \<20 ng/ml). prior to definitive breast cancer surgery, vitamin d level, parathyroid level, and calcium will be reassessed. samples of the patients original core biopsy and pathology specimen from their definitive surgical therapy will undergo gene expression profiling. the ultimate plan is to correlate baseline vitamin d levels with classic prognostic and predictive markers to see if breast cancer biology is impacted by baseline vitamin d level and by vitamin d supplementation and to see if vitamin d supplementation results in gene expression changes similar to those of the vitamin d sufficient group.

Eligibility criteria:
inclusion criteria: * undergoing core needle biopsy for a breast abnormality suspicious for breast cancer. * has undergone a core needle biopsy demonstrating breast cancer and has not yet had any further therapy, provided the core needle biopsy is available for analysis. * no prior therapy for breast cancer within the past 5 years. * 18 years of age or older. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * history of parathyroid disease, hypercalcemia, or kidney stones. * supplemental vitamin d other than from a standard multiple vitamin or from standard formulations of calcium and vitamin d (eg, calcium citrate with vitamin d) within the prior 6 months. * history of renal failure requiring dialysis or kidney transplantation. * pregnant or nursing * receiving supplemental calcium \> 1200 mg calcium per day during study. * initial treatment of breast cancer will not be with breast-conserving surgery or mastectomy. * locally-advanced breast cancer * plans for neoadjuvant chemotherapy, hormonal therapy, or other systemic therapy * plans for preoperative radiation therapy * plans for breast cancer surgery, and does not allow for at least 10 days of vitamin d intervention. * any condition potentially interfering with subjects ability to comply with taking study medication. * any medical condition that would potentially interfere with vitamin d absorption, such as celiac sprue, ulcerative colitis. * current participation in another research study that would increase risk to subject, in the opinion of the investigators